Jul 18, 2012 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
New lab test market could open up if research findings lead to a useful clinical laboratory test that predicts prostate cancer recurrence
Over the past decade, clinical laboratory tests that can predict the occurrence or recurrence of breast cancer have opened up a profitable market for the companies that developed these technologies. Now, new research may become the basis of a useful medical laboratory test that could be predictive of prostate cancer relapse.
Of course, pathologists know that several years of further development and regulatory approvals will be needed before this research produces a lab test for clinical use that can reliably predict the recurrence of prostate cancer. What makes this development exciting is that there is a huge and untapped demand to help men with prostate cancer and their physicians make informed decisions about treatment options and long-term prognosis. (more…)
May 25, 2012 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Sensitivity and specificity of test kit for over-the-counter sale does not equal that of HIV assays performed in licensed and accredited clinical laboratories
Despite concerns about the potential for false positive results, an in-home rapid HIV test kit designed to be sold to consumers in pharmacies and other retail outlets cleared one more hurdle on the path to winning clearance by the Food and Drug Administration (FDA) to come to market.
On May 15, the 17 voting members of FDA’s Blood Products Advisory Committee (BPAC), concluded that the benefits of the OraQuick in-home HIV test outweigh the potential risks for consumers, according to a story published at cbsnews.com. The FDA advisory panel’s decision came despite earlier reported concerns regarding decreased accuracy of the OTC test when performed by consumers as compared to results from the professional-use version.
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Dec 28, 2009 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Specialist physicians in Quebec question why the outside review of ER and HER2 breast cancer pathology test results used a 1% standard versus a 10% standard
Public debate in Quebec about inaccurate tests for breast cancer by the province’s pathology laboratories has turned attention to an area of pathology testing which is seldom discussed in public forums. It is the situation where there is often significant variability in rate of false positives and false negatives reported by different pathology laboratories performing the same tests for breast cancer and other diseases.
Quebec’s media coverage about problems with its pathology laboratories and inaccurate breast cancer tests was reported last week by Dark Daily in the e-briefing titled “PART ONE: More Debate in Quebec about How Pathology Labs Performed Inaccurate Breast Cancer Tests” . Here in Part Two, we describe how Quebec’s medical specialists are calling attention to another source of problems. This is how the use of various standards for evaluating breast cancer specimens can contribute to different rates of false positive and false negative results on pathology tests reported by pathology laboratories in the province.
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Dec 23, 2009 | Laboratory News, Laboratory Pathology
Results of retesting 2,856 women were made public last week, putting pathology in the media spotlight
In Quebec, concerns continue about the accuracy of breast cancer testing performed in the province. Last Wednesday, Quebec’s Health Minister, Yves Bolduc released the results from a project that retested breast cancer tissue from 2,856 women. This review involved cases where the original pathology analysis for estrogen receptor (ER) or HER-2 marker status by immunohistochemistry (IHC) had occurred between April 1, 2008, and June 1, 2009. (more…)
